PIRFACT 801 Tablet 10's
Key Information
Generic Name
Generic Name Pirfenidone 801 mg
Manufacturer
Sun Pharmaceutical Industries Ltd
Variant
10 Tablet(s) in a Strip
Country of Origin
India
Detailed Information
Introduction
INTRODUCTIONPIRFACT 801 contains Pirfenidone which belongs to the group of medicines called Anti-fibrotics or Anti-inflammatory agents. It is used in the management of mild to moderate Idiopathic pulmonary fibrosis in adults. Idiopathic pulmonary fibrosis is a condition in which the tissues in the lungs (alveoli) become swollen and scarred over time and making it difficult to breathe. This makes it hard for the lungs to work properly. Avoid smoking while using PIRFACT 801 as it reduces the effect of this medicine. Also, avoid drinking grapefruit juice as it may lead to unwanted effects. Avoid exposure to the sunlight (including sunlamps) while taking PIRFACT 801. Wear sunblock (sunscreen SPF 50) daily and cover your arms, legs and head to reduce exposure to sunlight. PIRFACT 801 is not recommended for use in patients with severe or end-stage liver or kidney disease. Before taking PIRFACT 801 inform your doctor if you have mild to moderate liver disease, kidney problems or photosensitivity reactions. PIRFACT 801 is not recommended for use in pregnant women unless advised by your doctor. It is not known whether PIRFACT 801 passes into breast milk, hence consult your doctor before taking this medicine. PIRFACT 801 is not recommended for use in children and adolescents below 18 years of age. PIRFACT 801 should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking this medicine. The most common
Uses
OF PIRFACT 801 Manages idiopathic pulmonary fibrosis
How It Works
PIRFACT 801 works by exhibiting anti-inflammatory, antioxidant and antifibrotic properties that suppress the factors (transforming growth factor - TGF) causing scarring and swelling of the tissues. As a result, it manages and controls the fibrosis of the tissues resulting in improving lung function.
Directions for Use
Take PIRFACT 801 as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Side Effects
taking PIRFACT 801 are infections of the throat or the airways and sinusitis, nausea, stomach problems such as acid reflux, vomiting, constipation, diarrhoea, indigestion or stomach upset, weight loss, decreased appetite, difficulty sleeping, tiredness, dizziness, headache, shortness of breath, cough, joint pains, etc. Consult your doctor if any of the above side effects worsen. USES OF PIRFACT 801 Manages idiopathic pulmonary fibrosis HOW PIRFACT 801 WORKSPIRFACT 801 works by exhibiting anti-inflammatory, antioxidant and antifibrotic properties that suppress the factors (transforming growth factor - TGF) causing scarring and swelling of the tissues. As a result, it manages and controls the fibrosis of the tissues resulting in improving lung function. DIRECTIONS FOR USETake PIRFACT 801 as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. SIDE EFFECTS OF PIRFACT 801COMMON infections of the throat or the airways and sinusitis, influenza and/or common cold nausea stomach problems such as acid reflux, vomiting, constipation, diarrhoea, indigestion or stomach upset weight loss decreased appetite difficulty sleeping tiredness, dizziness, headache shortness of breath cough joint pains bladder infections feeling sleepy change in taste sensation hot flushes bloating, abdominal pain and discomfort, heartburn, and flatulence elevated liver enzymes sunburn or skin reactions due to exposure in the sun or to sun lamps skin problems such as rashes, itchy skin, redness, dry skin muscle pain weakness or feeling low in energy chest pain UNCOMMON headache, dizziness, confusion, weakness, muscle cramps or nausea and vomiting (due to low levels of sodium in the blood) RAREStop taking PIRFACT 801 and contact your doctor immediately if you experience any of the following side effects: signs of angioedema or serious allergic reactions or anaphylaxis such as urticaria, itching, swelling of the face, lips, tongue or throat causing difficulty in breathing or feeling faint abnormal liver functions such as yellowish discolouration of skin and white of the eye, dark urine, itching of the skin, pain on the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily and tiredness signs and symptoms of Stevens-Johnson Syndrome or toxic epidermal necrolysis such as fever and flu-like symptoms followed by reddish or circular patches on the trunk, often with central blisters, peeling of the skin, ulcers on mouth, throat, eyes, nose, and genitals
Warnings & Precautions
& PRECAUTIONSPREGNANCYPIRFACT 801 is not recommended for use if you are pregnant, planning to become pregnant or think you might be pregnant as the potential risks to the unborn child are unknown. Consult your doctor before taking PIRFACT 801. BREASTFEEDINGIt is not known whether PIRFACT 801 pass through the breast milk, hence, consult your doctor before taking PIRFACT 801. DRIVING AND USING MACHINESDo not drive or operate any machines if you feel dizziness, or tiredness after taking PIRFACT 801. KIDNEYPIRFACT 801 is not recommended for use in patients with severe or end-stage kidney disease (requiring dialysis). It should be used with caution in patients with mild to moderate kidney problems. Contact your doctor before taking PIRFACT 801. LIVERPIRFACT 801 is not recommended for use in patients with severe or end-stage liver disease. It should be used with caution in patients with mild to moderate liver disease. Contact your doctor before taking PIRFACT 801. ALLERGYDo not take PIRFACT 801 if you are allergic to Pirfenidone. OTHERSBefore taking PIRFACT 801, inform your doctor if you: have photosensitive reactions (more sensitive) to sunlight are a smoker have Stevens-Johnson syndrome and toxic epidermal necrolysis Use in pediatrics: PIRFACT 801 is not recommended for use in children and adolescents under 18 years of age. Contact child’s doctor for advice. Use in geriatrics: PIRFACT 801 should be taken with caution in elderly patients (above 65 years of age) Your doctor will decide the dose, duration of the management and its frequency for you depending on the severity of your existing condition and other comorbid diseases.
Drug Interactions
SA. Drug-Drug Interaction: Before taking PIRFACT 801, inform your doctor if you are taking any of the following medicines: fluvoxamine (used to manage depression and obsessive-compulsive disorder) chloramphenicol, enoxacin, ciprofloxacin, doxycycline (used to manage bacterial infections) amiodarone, propafenone, mexiletine, quinidine (used to manage heart rhythm disorders) omeprazole, esomeprazole (used to manage indigestion, acid reflux) rifampicin, rifampin (used to manage tuberculosis). methoxsalen (used to manage skin diseases like psoriasis, and vitiligo) oral contraceptives such as ethinyl estradiol or norethindrone (used to prevent pregnancy) miconazole, fluconazole, voriconazole, terbinafine (used to manage fungal infections) moclobemide, fluoxetine, duloxetine, paroxetine (used to manage depression) bupropion (helps to stop smoking) cinacalcet (used to manage hyperparathyroidism) phenytoin, carbamazepine (used to manage fits) B. Drug - Food interaction: Avoid drinking grapefruit juice while taking PIRFACT 801 as it may lead to unwanted effects. Consult your doctor before taking PIRFACT 801. Overdosage: If you or anyone else accidentally take too much of PIRFACT 801, consult your doctor immediately or visit the nearby hospital. SYNOPSIS Drug : Pirfenidone Pharmacological Category : Anti-fibrotics or Anti-inflammatory agents Therapeutic Indication : Mild to moderate Idiopathic Pulmonary Fibrosis Dosage Forms : Tablet MORE INFORMATION Keep PIRFACT 801 out of reach of children Store at room temperature